Several years ago when there was a big hullabaloo about the possibility of obtaining drugs from Canada at Canadian prices, the powers that be warned the us that they couldn't vouch for their safety. Well I thought that was a bunch of poppycock and just business as usual, our government doing what they do best, protecting big pharma's pocketbook. So imagine my surprise (not!) when the drug heparin started causing allergic reactions and death in patients here in the US. It just so happens that one of the active ingredients comes from............guess where? Haven't guessed yet? Well China! Surprise, surprise. Now it's no secret that Chinese products have been trying to kill us for years. If antifreeze laced toothpaste doesn't kill you, they will kill your kids with lead paint in their toys. Now the FDA, charged with protecting the public has screwed up. Read on:
In fairness to the FDA, they thought they'd inspected the plant:
The American market for the generic drug heparin is shared by Baxter and APP Pharmaceuticals. Baxter gets its product from Scientific Protein Laboratories, a Wisconsin-based company that finishes the drug both in the United States and in China, according to Baxter spokeswoman Erin Gardiner. Baxter sells 35 million vials of heparin a year, she said.The active ingredient used by Baxter and APP is derived from an enzyme found in pig intestines and is made solely in China. But the reported problems have involved only Baxter's version of the drug, which uses an active ingredient from a manufacturing plant started by the Wisconsin firm called Changzhou SPL, west of Shanghai. It was opened in 2004.
According to the FDA, that plant has not been inspected by Chinese drug regulators, who sometimes do not visit facilities manufacturing for foreign markets. Baxter has said that it had sent its own representatives there to ensure proper manufacturing procedures were being followed six months ago.
Gardiner said that the company has detected slight variations between different lots coming from China.
When the application from the Changzhou firm was activated, Famulare said, it was mistaken for another Chinese firm that made a different drug. The FDA accepts previous positive inspections as sufficient proof that a company is doing a good job, and it can approve new drugs or drug ingredients based on that record.
An honest mistake, perhaps. But a potentially deadly one.
Looking in the wrong places, looking the other way, looking to help your friends. The Bush administration.
via Effect Measure
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